Related Manuals for Infinium CLEO
Summary of Contents for Infinium CLEO
- Page 1 CLEO Patient Monitor USER’S MANUAL Ver 1.3 © 2014 Infinium Medical Inc. All rights reserved. Issued Date: Sept 28, 2014...
- Page 2 Toll Free (US call only): 866-918-8434 International: 1-727-531-8434 Fax: 1-727-531-8436 To obtain information about a warranty, if any, for this product, contact Infinium Medical Inc, Technical Services or your local Infinium Medical, Inc. representative. RESPIRONICS is a trademark of PHILIPS RESPIRONICS...
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Page 3: Table Of Contents
User’s manual of CLEO Patient Monitor CONTENTS SAFETY INFORMATION ..................... 4 INTRODUCTION ......................... 6 INTENDED USE ........................6 ABOUT THIS MANUAL ......................6 CONTROLS, INDICATORS, AND SYMBOLS ..............7 FRONT AND SIDE PANEL ..................... 7 REAR PANEL .......................... 8 SYMBOLS ..........................9 DISPLAY SCREEN PARTITION .................. - Page 4 User’s manual of CLEO Patient Monitor NIBP ERROR MESSAGES ....................27 MAINTAINENCE AND CLEANING ..................27 QUICK TEMP MONITORING .................... 28 ABOUT BODY TEMPERATURES ..................28 GENERAL INFORMATION ....................28 SAFETY AND WARING ....................... 29 INSTRUCTION FOR USE ..................... 29 QTEMP PARAMETER SETUP .....................
- Page 5 User’s manual of CLEO Patient Monitor FIGURES Figure 1: Front and Side Panel ..................7 Figure 2: Rear View for Main Unit ................8 Figure 3: Tree Diagram for System Setup Menu ............12 Figure 4: Window for Ethernet IP Address Setup ............13 Figure 5: Tree Diagram for Pleth Menu ..............
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Page 6: Safety Information
Read all text surrounding all precautionary information. The CLEO can be powered by an internal battery that provides 3 hours of monitoring from fully charged batteries. The batteries are continuously recharged when AC power is connected to the monitor. - Page 7 CAUTION: When connecting the CLEO to any instrument, verify proper operation before clinical use. Both the CLEO and the instrument connected to it must be connected to a grounded outlet. Accessory equipments connected to this patient monitor must be certified according to the respective IEC standards (e.g.
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Page 8: Introduction
It must be used in conjunction with clinical signs and symptoms. ABOUT THIS MANUAL This manual explains how to set up and use the CLEO Patient Monitor. Important safety information relating to general use of the CLEO appears before this introduction. Other important safety information is located throughout the text where applicable. -
Page 9: Controls, Indicators, And Symbols
User’s Manual of CLEO Patient Monitor CONTROLS, INDICATORS, AND SYMBOLS FRONT AND SIDE PANEL REAR PANEL SYMBOLS FRONT AND SIDE PANEL Figure 1: Front and Side Panel Function Icon POWER SWITCH This toggle switch turns the secondary power from on to off. -
Page 10: Rear Panel
User’s Manual of CLEO Patient Monitor REAR PANEL Figure 2: Rear View for Main Unit Function Icon Battery Access AC Input and Fuse 100/240V～50/60Hz, 30VA, The AC power connection is where the power cord F2AL 250V is connected to the monitor. The AC power fuse must be replaced with the same type of fuse. -
Page 11: Symbols
User’s Manual of CLEO Patient Monitor SYMBOLS The following symbols may appear on the packaging, monitor or in user’s manual: Type BF Applied Part Manufacture’s Serial Number Fuse Information Date of Manufacture Manufacturer Fragile Contents of the transport package are fragile; therefore, it should be handled with care. -
Page 12: Display Screen Partition
User’s Manual of CLEO Patient Monitor DISPLAY SCREEN PARTITION There are nine groups for module combination in all. The user can choose what to measure as required in Display Mode. The module combinations are as below: SpO EtCO ... - Page 13 User’s Manual of CLEO Patient Monitor ⑦SpO ⑧ SpO ⑨EtCO + EtCO + NIBP + NIBP + QTemp + NIBP + QTemp - 11 -...
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Page 14: System Setup
User’s manual of CLEO Patient Monitor SYSTEM SETUP System Setup includes: Factory Setup, Demo Switch, Sound Volume, Brightness, Alarm Switch, Display Mode, Clock Setup, Default Config, Save Config and etc. Press the SETUP button to open the System Setup menu, the tree diagram is as... -
Page 15: Sound Volume
User’s manual of CLEO Patient Monitor Figure 4: Window for Ethernet IP Address Setup If click OK item, the Ethernet IP address setup of the Patient Monitor is set and saved. This IP address is available only when the patient monitor is re-powered on. -
Page 16: Screen Calibration
User’s manual of CLEO Patient Monitor is to display as you want. [NOTE] 1. The module combination ‘EtCO + NIBP + QTemp’ exists only when the EtCO module type is Internal. 2. The display mode will switch to ‘EtCO +NIBP’ if the EtCO module type changes to External under the ‘EtCO... -
Page 17: How To Monitor
5. Set monitoring parameters (see chapters below) ; 6. Enter the monitoring state. [CAUTION]: If the CLEO is to be stored for a period of 2 months or longer, notify service personnel to remove the battery from the monitor prior to storage. Recharge the battery when the battery has not been recharged for 2 or more months. -
Page 18: Alarm & Sound
When a low priority alarm occurs, a non-flashing alarm message appears in the message area. If more than one low priority alarm is present, the alarm messages “rotate”. On the CLEO the alarm led color will change to a solid yellow for a low priority alarm A medium priority alarm is activated when a parameter is outside its alarm limits. -
Page 19: Sound
User’s manual of CLEO Patient Monitor When the high-priority No breath alarm occurs, the alarm led color will flash red. A non-flashing No breath message appears in the message area and will override any other messages that may be present (there is no message “rotation” in this case). -
Page 20: Spo2 Monitoring
User’s manual of CLEO Patient Monitor SPO2 MONITORING SPO2 MONITORING PRINCIPLE SPO2 SENSOR INSTALLLATION SPO2 WAVEFORM SETUP SPO2 PARAMETER SETUP MEASUREMENT LIMITATIONS SPO2 ERROR MESSAGES NELLCOR INFORMATION SPO2 MONITORING PRINCIPLE Arterial oxygen saturation is measured by a method called pulse oximetry. It is a continuous, non-invasive method based on the different absorption spectra of reduced hemoglobin and oxyhemoglobin. -
Page 21: Spo2 Parameter Setup
User’s manual of CLEO Patient Monitor MODULE TYPE There are three SpO modules to choose from: Infinium, Nellcor. For more detail please contact local distributor or service engineer. SWEEP SPEED Choose from 12.5mm/s or 25.0mm/s, and the factory setting is 25 mm/s. -
Page 22: Measurement Limitations
User’s manual of CLEO Patient Monitor MEASUREMENT LIMITATIONS The measurement is determined by the pulse of the blood flow in the arterial blood vessels. The arterial blood flow may decrease to such a level that it cannot be measured under the following conditions: ... -
Page 23: Nellcor Information
User’s manual of CLEO Patient Monitor NELLCOR INFORMATION TRADEMARK AND LICENSING LABELS NELLCOR PATENS This device is covered under one or more the following U.S. Patents: 4,802,486; 4,869,254;4,928,692; 4,934,372; 5,078,136; 5,351,685; 5,485,847; 5,533,507; 5,577,500; 5,803,910;5,853,364; 5,865,736; 6,083,172; 6,463,310; 6,591,123; 6,708,049; Re.35,122 and international equivalents U.S.A international patents pending. -
Page 24: Nibp Monitoring
User’s manual of CLEO Patient Monitor NIBP MONITORING SUMMARY ON NIBP MONITORING NIBP CUFF FITTING NIBP MONITORING INITIALIZATION NIBP PARAMETER SETUP NIBP LIST OBSERVATION MEASUREMENT LIMITATIONS NIBP ERROR MESSAGES MAINTAINENCE AND CLEANING... -
Page 25: Nibp Monitoring Initialization
User’s manual of CLEO Patient Monitor [WARNING] The width of the cuff should be either 40% of the limb circumference (50% for neonates) or 2/3 of the upper arm length. The inflatable part of the cuff should be long enough to encircle 50-80% of the limb. Using the wrong cuff size can cause erroneous readings. - Page 26 User’s manual of CLEO Patient Monitor ALARM SWITCH ON and OFF for choice, the factory setting is ON. If the NIBP value is above or below the NIBP alarm limit, and the settings are set to ON, then the alarm will be activated. When the settings are set to OFF, the alarm indicator will not light up;...
- Page 27 User’s manual of CLEO Patient Monitor the information indicating area will read "Auto measuring ended！". The monitor will then continue automatically measuring until the mode is changed. If the NIBP value cannot be measured, the NIBP parameter area will display any error messages and will attempt to take the measurement again up to three times.
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Page 28: Nibp List Observation
User’s manual of CLEO Patient Monitor ALARM LIMIT SETUP SYS UPPER LIMIT SYS LOWER LIMIT DIA UPPER LIMIT DIA LOWER LIMIT Limits (mmHg) (mmHg) (mmHg) (mmHg) Patient Type 30~240 30~240 15~180 15~180 Adult Factory setting:150 Factory setting:100 Factory setting:90 Factory setting:50... -
Page 29: Nibp Error Messages
User’s manual of CLEO Patient Monitor CARDIAC ARRHYTHMIA`S Measurements will be unreliable or impossible to take if the patient’s cardiac arrhythmia has caused an irregular heartbeat. It will also take longer to take the measurement. HEART-LUNG MACHINE It will not be possible to take measurements, if the patient is connected to a heart-lung machine. -
Page 30: Quick Temp Monitoring
User’s manual of CLEO Patient Monitor QUICK TEMP MONITORING ABOUT BODY TEMPERATURES GENERAL INFORMATION SAFETY AND WARING INSTRUCTION FOR USE QTEMP PARAMETER SETUP MAINTAINENCE AND CLEANING ABOUT BODY TEMPERATURES It is a common myth that 98.6°F (37°C) is the “normal body temperature.” The truth is that 98.6°F (37°C) is an average body temperature. -
Page 31: Safety And Waring
User’s manual of CLEO Patient Monitor SAFETY AND WARING Read this booklet thoroughly before using the FILAC 3000 electronic thermometer. Do not use this device near flammable anesthetics. Not suitable for use in the presence of flammable anesthetic mixture with air, oxygen or nitrous oxide. - Page 32 User’s manual of CLEO Patient Monitor Insert the probe end into a cover in the box. Push the handle firmly until you feel the cover “snap” into place. Take appropriate temperature measurement (oral, axillary or rectal). Eject the used cover into bio-waste container by pressing top button.
- Page 33 User’s manual of CLEO Patient Monitor [NOTE] Accurate body temperature readings can only be obtained in one of these two “heat pocket” locations as shown. Temperatures taken in other mouth locations will result in inaccurate body temperature readings Patient’s mouth must be CLOSED.
- Page 34 User’s manual of CLEO Patient Monitor Direct Mode The FILAC 3000 electronic thermometer normally operates in Predictive Mode to provide fast and accurate temperature measurements. However, in instances when no measurement site is detected or the temperature does not stabilize, the thermometer will automatically switch to Direct Mode and act as a temperature monitor.
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Page 35: Qtemp Parameter Setup
User’s manual of CLEO Patient Monitor the °C/°F button again to change between the Celsius and Fahrenheit scales. Withdrawing the probe from the probe well erases last temperature memory. If the most recent temperature measurement was incomplete or out of range, dashes will appear on the display during the recall operation. -
Page 36: Qtemp List Observation
User’s manual of CLEO Patient Monitor Can be ON or OFF. The factory setting is ON. If the QTemp value is above or below the QTemp alarm limit, and the alarm is ON, then the alarm will be activated. When the alarm is OFF, the alarm indicator will not light up; the corresponding alarm parameter will not flash. -
Page 37: Maintainence And Cleaning
User’s manual of CLEO Patient Monitor MAINTAINENCE AND CLEANING The entire device may be easily wiped clean. Water temperature should not exceed 130° F (55° C). Do not submerge or soak under water. A mild detergent may be added to water. Use of cleaners such as Spray NineTM*, PhisohexTM*, HibiclensTM*, or Vesta-SydeTM* CidexTM* may result in damage to the thermometer case. -
Page 38: Etco2 Monitoring
User’s manual of CLEO Patient Monitor ETCO2 MONITORING THEORY OF OPERATION WARNINGS, CAUTIONS, NOTES ABBREVIATIONS AND TERMINOLOGY ZEROING THE CO2 MODULE PATIENT AND TUBING PREPARATION ETCO2 WAVEFORM SETUP ETCO2 PARAMETER SETUP ADVANCED SETUP ... -
Page 39: Abbreviations And Terminology
User’s manual of CLEO Patient Monitor appearance the patient and the sampling line. Replace line if needed. DO NOT operate the CO Module when it is wet or has exterior condensation. DO NOT apply excessive tension to any cable. -
Page 40: Patient And Tubing Preparation
EtCO icon on the left panel of monitor. [WARNING]: Don’t hot plug EtCO module, that is make sure that the CLEO is powered off before Insert the connector of CO sensor into EtCO socket. Otherwise... -
Page 41: Etco2 Waveform Setup
User’s manual of CLEO Patient Monitor mouth. If a standard nasal CO sampling cannula is used with these patients, the EtCO number and capnogram will be substantially lower than actual. When using the Nasal or Oral/Nasal CO sampling kits with oxygen delivery, place the cannula on the patient as shown above and then attach the oxygen supply tubing to the oxygen delivery system and set the prescribed oxygen flow. -
Page 42: Etco2 Parameter Setup
User’s manual of CLEO Patient Monitor From 6.25 mm/s, 12.5 mm/s and 25 mm/s for choice, the factory setting is 6.25 mm/s. SWEEP COLOR From Yellow, White, Blue, Red, Green and Cyan for choice, the default setting is Cyan. MODULE TYPE There are two items for choice: External, Internal. -
Page 43: Advanced Setup
User’s manual of CLEO Patient Monitor AWRR ALARM LOW The range is 5～100 mmHg，and the factory setting is 5 mmHg. The single-step adjustable length of alarm limit above is 1 mmHg. ASPHYXIA DELAY This setting is used to set the no breaths detected time-out. This time-out is the time... -
Page 44: Calibration
User’s manual of CLEO Patient Monitor when initially connecting to the CO module and whenever there is a change in the conditions at the patient airway. In the CO module, the temperature of the gas in the airway also effects the CO measurement. -
Page 45: Status/Error Messages
User’s manual of CLEO Patient Monitor STATUS/ERROR MESSAGES Messages Descriptions Sensor Off The CO sensor is not connected Sensor Warm Up One of the following conditions exist: Sensor under temperature Temperature not stable Source Current unstable Sensor Over Temp Make sure sensor is not exposed to extreme heat (heat lamp, etc.). -
Page 46: Recall Data
The user can set by touching the patient ID area at the top left corner to open the patient setup menu. You can have settings as below. CLEO Patient Monitor can save five groups patient information for recall in total. -
Page 47: Clock Setup
User’s manual of CLEO Patient Monitor CLOCK SETUP In order to review data easily and intuitively, you should have set a right time. Touch the time area at the top right corner to open the time setup menu. Also you can set the clock in the System Setup Menu. -
Page 48: Figure 18: Tabular Trend For Spo
User’s manual of CLEO Patient Monitor SPO2 REVIEW The SpO History Data review is as below: Figure 18: Tabular Trend for SpO ETCO2 REVIEW The EtCO History Data review is as below: Figure 19: Tabular Trend for EtCO - 46 -... -
Page 49: Figure 20: Tabular Trend For Nibp
User’s manual of CLEO Patient Monitor NIBP REVIEW The NIBP History Data review is as below: Figure 20: Tabular Trend for NIBP QTEMP REVIEW The QTemp History Data review is as below: Figure 21: Tabular Trend for QTemp - 47 -... -
Page 50: Battery Operation
It is recommended that the internal battery is replaced by qualified service personnel every 24 months. [CAUTION]: If the CLEO is to be stored for a period of 2 months or longer, notify service personnel to remove the battery from the monitor prior to storage. Recharge the battery when it has not been charged for 2 or more months. -
Page 51: Disposal Of Device Components
User’s manual of CLEO Patient Monitor DISPOSAL OF DEVICE COMPONENTS Follow local governing ordinances and recycling instructions regarding disposal or recycling of device components, including batteries. - 49 -... -
Page 52: Cleaning
• Inspect the safety relevant labels for legibility. [WARNING]: Do not spray, pour, or spill liquid on CLEO, its accessories, connectors, switches, or openings in the chassis. Do not immerse the CLEO or its accessories in liquid or clean with caustic or abrasive cleaners. -
Page 53: Specifications
User’s manual for CLEO Patient Monitor SPECIFICATIONS SAFETY Meet the requirement of EN60601 series, CE marking according to MDD93/42/EEC Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide... - Page 54 User’s manual for CLEO Patient Monitor 15～200 (mmHg) Neonatal Mode 40～135 (mmHg) 15～100 (mmHg) Resolution: 1mmHg Maximum Mean Error: ±5 mmHg Pressure Accuracy: Maximum Standard Deviation: 8 mmHg Overpressure Protection: Adult Mode 280 (mmHg) Neonatal Mode 150 (mmHg) Alarm Limit: 30～240 mmHg...
- Page 55 User’s manual for CLEO Patient Monitor ETCO Calculation: Method: Peak of the expired CO waveform Selections: 1 breath, 10 s, 20 s Inspired CO Measurement: Range: 3～50 mmHg Method: Lowest reading of the CO waveform in the previous 20 s...
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Page 56: Emc
ELECTROMAGNETIC IMMUNITY This section constitutes the guidance and CLEO Patient Monitor’s declaration regarding electromagnetic immunity. The CLEO Patient Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the CLEO Patient Monitor should ensure that it is used in such an environment. - Page 57 Electromagnetic environment level level – guidance Portable and mobile RF communications equipment should be used no closer to any part of the CLEO Patient Monitor, including cables, than the recommended separation distance, which calculated using the formula applicable to the frequency of the transmitter.
- Page 58 If the measured field strength in the location in which the CLEO Patient Monitor is used exceeds the applicable RF compliance level, verify that the CLEO Patient Monitor works normally. If you observed abnormal performance, you may need to reorient or relocating the CLEO Patient Monitor.